Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

25 October 2013

US pharma giant Merck & Co (NYSE: MRK) yesterday (October 24) provided an overview of the clinical trial program for V503, the company’s investigational 9-valent human papillomavirus (HPV) vaccine, to the Advisory Committee on Immunization Practices in the USA.

Merck said that the pivotal efficacy trial is complete, the primary endpoints have been met and the company expects to submit a Biologics License Application for V503 to the US Food and Drug Administration during the current year (2013).

The study evaluated the efficacy, immunogenicity and safety of V503 in females aged 16-26 years. Merck plans to present results from this study, as well as other results from the Phase III clinical program for V503, at the EUROGIN (EUropean Research Organization on Genital Infection and Neoplasia) congress in November.

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